The following data is part of a premarket notification filed by Bicore Monitoring Systems with the FDA for Bicore Smartcath Intratracheal Catheter.
Device ID | K935788 |
510k Number | K935788 |
Device Name: | BICORE SMARTCATH INTRATRACHEAL CATHETER |
Classification | Accessory To Continuous Ventilator (respirator) |
Applicant | BICORE MONITORING SYSTEMS 2-A FARADAY Irvine, CA 92718 |
Contact | Muir S Meinhold |
Correspondent | Muir S Meinhold BICORE MONITORING SYSTEMS 2-A FARADAY Irvine, CA 92718 |
Product Code | MOD |
CFR Regulation Number | 868.5895 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-12-06 |
Decision Date | 1995-07-03 |